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Tablets & Capsules September 2020 53 Reference 1. Takahiro Hiramura and Makoto Narushima, "Eye on Excipients," Tab- let & Capsules, March 2016, page 37. Dr. Yukiko Suganuma is in charge of technical support and marketing for Daicel in Japan (daicel-excipients@jp. daicel.com, daicel-excipients.com). Conclusion T h e c o - p r o c e s s e d e x c i p i e n t HiSORAD for direct-compression produced ODTs with excellent dis- integrability, compactability, hygro- scopic stability, and content unifor- mity. Future research might also be conducted to determine its applicabil- ity for continuous manufacturing. T&C Content uniformity in ODTs Direct compression is the simplest tableting method, contributing to both energy savings and cost advan- tages. However, maintaining content uniformity in direct-compression tab- lets can be challenging, because it requires powders with different phys- ical properties to be mixed directly without any preprocessing. This study evaluated the content unifor- mity of direct-compression ODTs made with the co-processed excip- ient using a lab-scale rotary tablet press. Tablet samples were taken ini- tially and at 20, 40, and 60 minutes, then the API content in each tab- let was evaluated, as shown in Fig- ure 6. The APIs were ibuprofen as a charged API and ascorbic acid as a non-charged API. Each formulation contained only 1 percent API. In ODTs with 58-micron ibu- profen particles, which is slightly smaller than the co-processed excip- ient's particle size, the coefficient of variation (CV) calculated from all obtained tablets was 1.0 percent. Similarly, the CV of ODTs using 142-micron ibuprofen particles was 2.4 percent, which seemed accept- able for such relatively large API particles at such a low dose (1.0 percent). The particle size of ascor- bic acid was similar to that of the co-processed excipient (92 microns), and the CV of ODTs with ascorbic acid was 2.2 percent, even though, because it is a non-charged API, there was no interaction between the ascorbic acid and the excipient. Additionally, no time-dependent segregation tendency was observed in any ODT. From these results, it seems that the co-processed excip- ient, with its nonspherical particle shape, provides adequate content uniformity for the direct-compres- sion process. Nonspherical particles are assumed to be able to hold APIs in a powder mixture. These findings suggest that the excipient is suit- able for formulations with various types of APIs with a wide range of physical properties. F-40 EXPERTS IN LIQUID CAPSULE FILLING & SEALING SECURING THE FLOW FULLY - AUTOMATIC CAPSULE FILLING SYSTEM • Ability to handle various dosage forms • Compact size • Easy conversion • Highly accurate filling www.qualicaps.com FULLY - AUTOMATIC CAPSULE SEALING SYSTEM • Automatic band positioning system • Highly accurate sealing with max. capacity of 125,000 capsules per hr. • Hermetic seal with two bands • Available with band detection and water additive system S-125